Despite the pharmaceutical industry’s essential function to make medicine that treats sick people, it is infamous for ethical ambiguity. Between the direct-to-consumer marketing of prescription meds, aggressive sales tactics, and potentially lethal drug components, the industry’s top corporations have faced recurring scrutiny over their trustworthiness.
Not everyone in pharma is involved in fraud, but the legal and ethical problems within the industry are without a doubt institutionalized. While it is important to take note of figures like Martin Shkreli, there are more pervasive issues that sustain pharmaceutical misconduct.
When the pharmaceutical supply chain functions properly from start to finish, the results can be lifesaving. When pharmaceutical companies enable fraud, however, they perpetuate a vicious cycle. The trouble starts with the manufacturing process.
How drugs are made
The global economy has facilitated faster production for prescription drugs, but it has also exposed them to new risks. As of 2013, approximately 80% of the active pharmaceutical ingredients in U.S. drugs were manufactured outside of the country. The infrastructure necessary to adequately oversea global manufacturing processes has not evolved nearly as fast as globalization itself.
This means that before their delivery to consumers, prescription drugs are at significant risk of contamination and outright counterfeiting. There is a higher risk of counterfeiting in countries with fewer resources devoted to pharmaceutical regulation, but this crime impacts Americans far more than most of us realize.
Counterfeit medications have killed patients around the world, and unfortunately counterfeiters are very adept at infiltrating mainstream drug outlets. Because fraudulent drugs are designed to look exactly like genuine, corporate-backed products, it’s very difficult for law enforcement, healthcare providers and pharmacies to spot them initially. We usually become aware that a particular drug is being widely counterfeited only after the patients who initially consumed it have suffered adverse side effects or worse.
Even when drugs are made in appropriate conditions, pharmaceutical companies often rush to get them FDA-approved to avoid elevated costs to themselves and, eventually, to consumers. Assessing the potential long-term or adverse side effects of any drug can take time. Rushing the process puts consumers at risk.
Pharmaceutical marketing and influence
From a public health perspective, pharmaceutical companies would be most constructive if they used the bulk of their considerable resources to conduct necessary research and develop innovative treatments around society’s most debilitating ailments. As it happens, though, nine out of the 10 biggest pharmaceutical companies in America spend significantly more on marketing than they do on research and development.
It isn’t trivial that America is one of only two countries in the world that allows drug companies to engage in direct-to-consumer marketing, but most of pharma’s marketing budget is actually allocated to targeting doctors. In 2012, the industry spent $3 billion marketing to consumers and $24 billion marketing to healthcare professionals.
Pharma’s well-oiled marketing machine has permeated the medical profession in ways that, frankly, aren’t easy for healthcare providers to avoid.
Officially, pharmaceutical companies send sales representatives to healthcare facilities to educate providers about their products. In the U.S., they are not legally permitted to instigate any financial arrangement with physicians that creates a conflict of interest. Furthermore, the Physician Payments Sunshine Act passed in 2010 to require the public disclosure of certain financial relationships between doctors and drug companies.
What concerns legislators and consumers are pharma’s unofficial yet extremely pervasive marketing tactics.
In 2012, GlaxoSmithKline was fined $3 billion for encouraging the inappropriate prescription of Paxil, Wellbutrin and Avandia. Among the allegations were unauthorized recommendation of Paxil to children and failure to disclose Avandia’s connection with increased heart risks.
GSK admitted to bribing doctors with expensive resort vacations, lavish gifts and kickbacks in exchange for the unapproved prescription of those three drugs.
GSK is not an outlier, and the practices in which it engaged are extremely common worldwide. Here are some of the methods major pharmaceutical companies have used to “educate” healthcare professionals about their products:
- Offering free meals, trips, gifts and perks
- Paying ghostwriters to help doctors publish papers in medical journals
- Offering paid speaking opportunities at conferences and conventions
- Downplaying or obscuring the serious side effects of certain drugs
- Recommending drugs for unapproved demographics or uses
- Leaving free drug samples without specifying safety information
For the world’s largest pharmaceutical companies, these tactics have worked. Otherwise, they wouldn’t keep funneling so much money into the process each year. What isn’t so clear is whether the tactics work for patients—the people pharmaceutical companies should ultimately be helping.
Diagnosis and dependency
Few people would deny the importance of timely and accurate diagnoses. For patients with conditions like heart disease, cancer and mental illness, the modern diagnostic process has saved lives.
The pharmaceutical supply chain as it stands, however, could actually be detrimental to the patients who need the industry’s resources and expertise the most. Pharma’s tactics may be causing over-diagnosis of certain conditions and incentivizing the over-prescription of drugs, many of which have unpublicized safety risks. The unfortunate result is nationwide dependency and, in some cases, death.
Research by the Mayo Clinic indicates that almost 70% of Americans take at least one prescription drug. More than 50% of Americans take two or more. 20% take five or more.
Pharma’s TV ads, persuasive physician education tactics and occasionally doctored research studies have normalized prescription drug use, but it’s important to question whether all of these drugs are truly helping us stay healthy. Our healthcare system should give doctors the realistic possibility of improving each patient’s health in the way that serves the patient’s best interest.
Pharma’s pressure on doctors could be encouraging some to prescribe drugs before asking the patient to initiate lifestyle changes or seek appropriate supplemental treatment. The patient may then learn only to suppress his symptoms, rather than managing and even resolving them with a more comprehensive and sustainable health plan.
This is a major problem in psychiatric treatment models. Psychiatric disorders are a very real issue, and they deserve appropriate attention. Many patients with mental illnesses struggle to have their disorders taken seriously; over-diagnosis does not help. It paints mental illness as an inevitable and easily medicated side effect of modern life, rather than the debilitating medical condition that it is for many people.
Even when drugs are necessary, each patient may have a different reaction. It is important that physicians have the necessary time, space and objectivity to carefully review patients’ medical history as well as the potential adverse effects of any samples or prescriptions. Pharmaceutical companies should freely offer that safety information, not hide it.
Under no circumstances should pharma reps be pushing the prescription of psychiatric drugs to vulnerable demographics for unapproved uses, and yet there have been multiple cases where pharma was accused of specifically targeting children and nursing homes. These tactics are not just unethical; they are fraudulent. Accordingly, the pharmaceutical industry paid around $3.75 billion in fraud penalties in 2013.
A call for accountability
Pharmaceutical companies like GSK have promised to reform their methods, and both Big Pharma and regulators are working to reform the supply chain so that drugs are made more safely in the first place. Even with these efforts, however, pharmaceutical fraud and ethical misconduct are still widespread.
With approximately 200,000 Americans dying from prescription drug use every year, we owe it to ourselves and each other to make sure the current pharmaceutical system is truly the best it can be.
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